Effect of Exposure to e-Cigarettes With Salt vs Free-Base Nicotine on the Appeal and Sensory Experience of Vaping: A Randomized Clinical Trial.
Effect of Exposure to e-Cigarettes With Salt vs Free-Base Nicotine on the Appeal and Sensory Experience of Vaping: A Randomized Clinical Trial.
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DOI：
10.1001/jamanetworkopen.2020.32757
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发表时间：
2021-01-04
影响因子：
13.8
通讯作者：
Tackett AP
中科院分区：
文献类型：
--
作者：
Leventhal AM;Madden DR;Peraza N;Schiff SJ;Lebovitz L;Whitted L;Barrington-Trimis J;Mason TB;Anderson MK;Tackett AP
接触盐与游离碱尼古丁配方的电子烟是否会改善电子烟的吸引力和感官体验？在这项随机临床试验中，119 名成人尼古丁或烟草产品使用者对尼古丁盐（添加苯甲酸）和尼古丁游离碱（不含苯甲酸）配方的电子烟的抽吸进行了评分。盐与游离碱尼古丁配方相比，在吸引力、甜味和顺滑度方面具有统计学上显着的更高评级，而苦味和涩味评级则较低。在这项研究中，电子烟中的酸性添加剂将尼古丁从游离碱转变为盐，似乎增强了电子烟的吸引力和感官体验，值得电子烟监管考虑。这项随机临床试验评估了控制接触含有盐和游离碱尼古丁配方的电子烟是否可以改善当前尼古丁或烟草产品成人使用者对电子烟的吸引力和感官体验。碱性游离碱尼古丁有苦味，对呼吸道有刺激性。高尼古丁电子烟（电子烟）产品含有酸性添加剂，可将尼古丁从游离碱转变为质子化盐化学形式，这可以改善电子烟的感官体验，特别是对于不习惯吸入游离碱尼古丁的从不吸烟者。确定暴露于含盐电子烟与游离碱尼古丁配方的电子烟是否会改善电子烟的吸引力和感官体验，以及尼古丁配方的效果是否因电子烟口味和可燃香烟吸烟状态而异。单次访问双盲参与者随机临床试验是在南加州的一个学术医疗中心门诊临床研究机构进行的。参与者是 2019 年 11 月至 2020 年 3 月期间招募的 119 名过去 30 天使用电子烟或可燃香烟的个人，年龄为 21 岁或以上。参与者使用烟弹式装置自行标准化抽吸每 10 种不同口味的电子烟溶液。每种口味均以盐（添加苯甲酸）和游离碱（不含苯甲酸）尼古丁配方形式给药，并具有相应的尼古丁浓度（平均值为 23.6 mg/mL）。 20 种溶液以随机分配的顺序施用。在吸完每种溶液后，参与者立即对吸引力和感官属性进行评分。自我报告的吸引力（喜欢、不喜欢[反向评分]和愿意再次使用评级的平均值）和 4 种感官属性（甜味、顺滑度、苦味和刺耳感；单独分析）在视觉模拟量表上，完全没有锚点和极端锚点（范围，0-100）。 119 名参与者中； 39 名（32.8%）为女性。平均 (SD) 年龄为 42.1 (14.4) 岁； 105 人（88.2%）曾经吸过可燃卷烟，66 人（55.5%）目前吸电子烟。盐与游离碱尼古丁配方产生更高的吸引力评级（盐与游离碱平均差异效应估计：b = 12.0；95% CI，9.9-14.1；P < .001）、甜味（b = 9.3；95% CI，7.1-11.4；P < .001），和平滑度 (b = 17.4; 95% CI, 15.2-19.6; P < .001) 及更低 苦味等级（b = −13.3；95% CI，-15.4至-11.2；P < .001）和粗糙度（b = −21.0；95% CI，-23.2至-18.7；P < .001）。尼古丁配方的效果在很大程度上适用于不同的口味，尼古丁盐的平滑度增强和粗糙度降低效果在从未吸烟者中比从不吸烟者中更强。在这项针对当前尼古丁或烟草产品成人使用者的随机临床试验中，控制接触含盐与游离碱尼古丁配方的电子烟似乎增加了产品吸引力并改善了电子烟的感官体验，特别是对于从不吸烟者而言。限制电子烟中酸性添加剂的监管政策可能会降低高尼古丁电子烟对那些不愿吸食散发刺激性气溶胶的电子烟的人群的吸引力。 ClinicalTrials.gov 标识符：NCT04399031
Does exposure to electronic cigarettes (e-cigarettes) in salt vs free-base nicotine formulations improve the appeal and sensory experience of vaping? In this randomized clinical trial, 119 adult nicotine or tobacco product users rated puffs from e-cigarettes in nicotine salt (benzoic acid added) and nicotine free-base (no benzoic acid) formulations. Salt vs free-base nicotine formulations resulted in statistically significant higher ratings of appeal, sweetness, and smoothness, and lower ratings of bitterness and harshness. In this study, acid additives in e-cigarettes that change nicotine from free base to salt appeared to enhance the appeal and sensory experience of vaping and merit consideration in e-cigarette regulation. This randomized clinical trial assessed whether controlled exposure to e-cigarette puffs with salt vs free-base nicotine formulations improved the appeal and sensory experience of vaping among adult current nicotine or tobacco product users. Alkaline free-base nicotine is bitter and a respiratory irritant. High-nicotine electronic cigarette (e-cigarette) products contain acid additives that change nicotine from a free-base to a protonated salt chemical form, which could improve the sensory experience of vaping, particularly among never smokers unaccustomed to inhaling free-base nicotine. To determine whether exposure to e-cigarettes with salt vs free-base nicotine formulations improves the appeal and sensory experience of vaping e-cigarettes and whether nicotine formulation effects differ by e-cigarette flavor and ever combustible cigarette smoking status. Single-visit double-blind within-participant randomized clinical trial was conducted in an academic medical center outpatient clinical research facility in Southern California. Participants were 119 individuals with past 30-day e-cigarette or combustible cigarette use aged 21 years or older recruited from November 2019 to March 2020. Participants self-administered standardized puffs of each 10 differently flavored e-cigarette solutions using a pod-style device. Each flavor was administered in salt (benzoic acid added) and free-base (no benzoic acid) nicotine formulations with commensurate nicotine concentrations (mean, 23.6 mg/mL). The 20 solutions were administered in randomly assigned sequences. Immediately after puffing each solution, participants rated appeal and sensory attributes. Self-reported appeal (mean of like, dislike [reverse-scored], and willingness to use again ratings) and 4 sensory attributes (sweetness, smoothness, bitterness, and harshness; analyzed individually) on visual analog scales with not at all and extremely anchors (range, 0-100). Of the 119 participants; 39 (32.8%) were female. The mean (SD) age was 42.1 (14.4) years; 105 (88.2%) were ever combustible cigarette smokers, and 66 (55.5%) were current e-cigarette users. Salt vs free-base nicotine formulations produced higher ratings of appeal (salt vs free-base mean difference effect estimate: b = 12.0; 95% CI, 9.9-14.1; P < .001), sweetness (b = 9.3; 95% CI, 7.1-11.4; P < .001), and smoothness (b = 17.4; 95% CI, 15.2-19.6; P < .001) and lower ratings of bitterness (b = −13.3; 95% CI, −15.4 to −11.2; P < .001) and harshness (b = −21.0; 95% CI, −23.2 to −18.7; P < .001). Nicotine formulation effects largely generalized across different flavors and the smoothness-enhancing and harshness-reducing effects of nicotine salt were stronger in never vs ever cigarette smokers. In this randomized clinical trial of adult current nicotine or tobacco product users, controlled exposure to e-cigarette puffs with salt vs free-base nicotine formulations appeared to increase product appeal and improve the sensory experience of vaping, particularly among never smokers. Regulatory policies limiting acid additives in e-cigarettes might reduce the appeal of high-nicotine e-cigarettes among populations deterred from vaping e-cigarettes that emit harsh aerosol. ClinicalTrials.gov Identifier: NCT04399031
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影响因子：
3.6
作者：
KOZLOWSKI, LT;KLEIMAN, RM
通讯作者：
KLEIMAN, RM
影响因子：
4.7
作者：
Pullicin, Alexa J.;Kim, Hyoshin;Lim, Juyun
通讯作者：
Lim, Juyun
影响因子：
4.2
作者：
Romberg, Alexa R.;Lo, Erin J. Miller;King, Brian A.
通讯作者：
King, Brian A.
影响因子：
5.2
作者：
Duell AK;Pankow JF;Peyton DH
通讯作者：
Peyton DH
DOI：
10.1111/j.2517-6161.1995.tb02031.x
发表时间：
1995-01-01
影响因子：
5.8
作者：
BENJAMINI, Y;HOCHBERG, Y
通讯作者：
HOCHBERG, Y